Background: Restless legs syndrome (RLS) is a chronic neurological disorder associated with sleep disturbance.
Objective: Prepare a drug evaluation of the non-ergot dopamine agonist ropinirole in RLS.
Methods: Review of scientific literature on RLS, particularly focusing on treatment with ropinirole.
Conclusion: Ropinirole has been studied for treatment of moderate to severe primary RLS in a comprehensive clinical development program. Ropinirole significantly improved symptoms of RLS, versus placebo, in patients with primary RLS. These improvements are supported by data from individual studies and pooled analyses. Significant improvements in RLS symptoms were observed within two nights of treatment. Ropinirole also produced significant benefits on objective measures of RLS motor symptoms, such as periodic leg movements, and subjective measures of sleep. Ropinirole was generally well tolerated.